Evaluation of Latanoprost Combined With Fractional Erbium- YAG Laser

NCT06239324 | Recruiting Phase 1 DMC

• 1 other identifier: Maha Nabil
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Alopecia areata (AA) an autoimmune disorder of hair follicles results in varying degrees of scalp, facial and body hair loss. Clinically, patients' presentation varies from patchy circumscribed scalp involvement to total body and scalp hair loss affects up to 2% of the general population. The exact pathobiology of AA has still remained elusive, while the common theory is the collapse of the immune privilege of the hair follicle caused by immunological mechanism. Multiple genetic, environment factors and psychological stress contribute to the pathogenesis of Alopecia Areata . Recent insights into the pathogenesis of AA have led to the development of new treatment strategies, such as Janus kinase inhibitors, biologics and several small molecular agents. In addition, modern therapies for AA, including antihistamines, platelet-rich plasma injection

Conditions

Alopecia Areata

Outcome Measures

Primary Outcomes (1)

• fractional Erbium YAG laser

  The Number of Participants With Treatment of fractional Erbium YAG laser assisted delivery of latanoprost versus micro needling with trans-epidermal latanoprost delivery to induce hair growth in alopecia areata.

  from baseline to 3 months after the fractional Erbium YAG laser treatment day.

Study Arms (2)

Fractional Erbium laser Technique (Group A)

ACTIVE COMPARATOR

About 35 patients with alopecia areata will Subject to fractional Erbium (Er-YAG) laser (Fotona Xs dynamics,Slovenia) with energy of 600 mj in short pulse mode (MSP) with spot size of 7 mm diameter, frequency of 3 Hz and pixel 3. Latanoprost( xalatan 0.005% ) is applied to the treated area for all participants.

Drug: Latanoprost

Micro needling Technique (Group B)

ACTIVE COMPARATOR

About 35 patients with alopecia areata will Subject to micro needling using electronic dermapen device (Dr Pen Derma PenUltima A6) which has a disposable head personalized for each patient and sterilized after each session. the dermapen will penetrate the skin with depth 0.6 mm. It will pass vertically over the affected area in a circular pattern until pinpoint bleeding appears. Latanoprost ( xalatan 0.005% ) is applied to the treated area for all participants.

Drug: Latanoprost

Interventions

Latanoprost DRUG

Comparing between Erbium YAG laser assisted drug delivery of latanoprost versus transepidermal latanoprost delivery by microneedling in alopecia areata treatment for all participants.

Also known as: fractional Erbium- YAG laser

Fractional Erbium laser Technique (Group A); Micro needling Technique (Group B)

Eligibility Criteria

• Age: 30 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients of both sexes with localized stable alopecia areata of the scalp of 3 months duration at least.

You may not qualify if:

• Acute or chronic infections.
• Pregnant or lactating women.
• Scarring alopecia.
• Alopecia totalis , Alopecia universalis and ophiasis.
• Autoimmune dermatological diseases.

Sponsors & Collaborators

• Egymedicalpedia: lead

Study Sites (1)

Qena Hospital

Qina, Egypt

RECRUITING

MeSH Terms

Conditions

Alopecia Areata

Interventions

Latanoprost

Condition Hierarchy (Ancestors)

Alopecia; Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Study Officials

• Soheir AbdelHamid Ali, Assist. Prof.

  Department of dermatology , Venerolgy and Andrology Faculty of Medicine Qena university

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maha Nabil Fahmy, Resident

CONTACT

01012004848; mahanabilsoady@gmail.com

Hassan Ibrahim, Assist.prof

CONTACT

01011524245; hassan.mohamed@med.svu.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2024
• First Posted: February 2, 2024
• Study Start: February 1, 2024
• Primary Completion: April 20, 2024
• Study Completion: May 1, 2024
• Last Updated: April 16, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)